FDA, HHS Probe Pharmacy Promos

US Food and Drug Administration Commissioner David Kessler has met with five state attorneys general or their assistants to discuss the AGs' concern at companies' use of drug promotion programs and the states' responsibility in these areas.

In particular, the AGs sought guidance on programs which pay pharmacists to switch patients from one medication to another; Minnesota AG Hubert Humphrey III had written to Dr Kessler that the FDA's "active involvement and assistance" was needed to deal with these cases. So far this year, state AG offices have acted against a number of these programs, with companies such as Upjohn and Miles being required to stop the programs and pay settlements to the state.

HHS Fraud Alert In addition, the Inspector General of Health and Human Services has issued a Fraud Alert relating to three drug promotion programs. These are: - Miles' program for Adalat CC (sustained-release nifedipine) which has led to 96,000 patients being converted from other products; - Caremark's provision of "a 'research grant' program in which physicians were given substantial payments for de minimis record-keeping tasks" related to the provision of Genentech's Protropin (human growth hormone), and; - the provision by Wyeth-Ayerst of rewards to pharmacists for reaching set prescribing levels for Inderal LA (propranolol). The FDA is currently investigating the possibility that Genentech made payments to physicians to prescribe Protropin to children who are of short stature but who do not have growth hormone deficiency.